# K072698: Confidant 2.5

- Pathway: 510(k) (Traditional)
- Applicant: Confidant, Inc.
- Decided: Nov 16, 2007 after 53 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K864318 (1987). 23 ancestors in all.
34 later devices descend from it; 8 cite it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062215: Confidant 2.0, Confidant, Inc. (2006) Summary page 1.
- K061087: Genesis Otc Monitor, Honeywell Hommed, LLC (2006) Summary page 1.

## Most influential descendants
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own
- K092635: Alcatel-Lucent Teleheath Manager (2009), 9 descendants of its own
- K113446: Vignet Telehealth Manager (2012), 8 descendants of its own
- K124000: Medapps 2.0 - Remote Patient Monitoring System (2013), 4 descendants of its own
- K112559: Medapps 2.0 Remote Patient Monitoring System (2011), 4 descendants of its own

## Indications for use
Confidant 2.5 is intended for personal use by out-of-hospital patients as a means to retrospectively collect and record physiologic measurements from home monitoring devices (including blood glucose meters, blood pressure cuffs and weight scales). The data is transmitted to a database server where customized messages are generated by the system and returned to the patient. The returned messages contain objective observations and motivational information intended to help the patient better understand and manage their health. Confidant 2.5 is an accessory device that collects data from a range of supported home-monitoring devices. The data is collected from the supported devices and sent to a central database server, using standard wireless technologies. Upon receipt of newly submitted patient data, the Confidant Server software will generate and send one or more feedback messages directly to the patient's cell-phone. The feedback messages are selected by the system based on the patient's currently submitted and recent historic data. Confidant 2.5 does not provide diagnosis of any disease or medical condition. Confidant 2.5 is not intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. Confidant 2.5 is not intended for emergency calls or for transmission or indication of any real-time alarms or time-critical data. This device is not intended as a substitute for direct medical supervision or emergency intervention. Confidant 2.5 is intended for over-the-counter use.

Source page: https://510kreport.com/device/K072698
Methodology: https://510kreport.com/methodology